Carcinoma, Non-Small-Cell LungPROFILERNCT03971175
Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC
A study testing Forceps biopsy and Cryobiopsy in people with Carcinoma, Non-Small-Cell Lung and Pathology, Molecular, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Study design Prospective multicentre explorative randomized single blinded study to evaluate accuracy of molecular genetic characterisation of NSCLC. Patients with suspected lung cancer are randomized in a 1:1-setting for bronchoscopic tumor tissue either by forceps or by cryobiopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Pathology, Molecular
- What is being tested?
- Forceps biopsy and Cryobiopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteGermany
- Study dates
- 19 Dec 2018to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent to the study and the study specific procedures prior to any study intervention
- Male or female patients aged ≥18 years
- Patients with primary diagnosis of suspected lung cancer OR Patients with known NSCLC and suspected relapse after therapy
- Bronchoscopically visible tumor
Who cannot join
- Preexisting malignancy other than NSCLC
- Contraindication for bronchoscopy according to the international guidelines, daily clinical practice and the local regulations with
- Patients with existing or at risk of pulmonary and cardiovascular decompensation
- Patients at increased risk of bleeding with antiplatelet agents except of aspirin (clopidogrel, ticlopidine, …) , anticoagulant therapy (prolonged PTT), thrombocytopenia (< 50.000/ul) or coagulopathy (prolonged in vitro bleeding time).
- Intolerance to sedation
- Unstable or immobile cervical spine
- Limited motion of the temporomandibular joint
- Previous enrolment in the present study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Tuebingen
Tübingen, 72076
Maik Haentschel, MD, +49707129 ext. 82711, maik.Haentschel@med.uni-tuebingen.de
Juergen Hetzel, MD, +49707129 ext. 82711, juergen.hetzel@med.uni-tuebingen.de
About this study
Official title: A Prospective, Randomized, Single Blinded Multicentre Trial to Evaluate Molecular Genetic Characterisation of Primary Diagnosed or Relapsed Non Small Cell Lung Cancer by Single or Combination of Diagnostic Procedures
Study design Prospective multicentre explorative randomized single blinded study to evaluate accuracy of molecular genetic characterisation of NSCLC. Patients with suspected lung cancer are randomized in a 1:1-setting for bronchoscopic tumor tissue either by forceps or by cryobiopsy. Apart from the bronchoscopic techniques liquid biopsy of peripheral blood and if feasible transbronchial needle aspiration with or without endobronchial ultrasound guidance are performed for in all patients.
Objectives
Read more
Primary Objective:
assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy
Secondary Objective:
assessment of differences in detection of molecular genetic alterations in NSCLC between
- liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
- combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
- naïve and processed tumor tissue specimen (eg. microdissection)
To assess differences in side effects e.g. periinterventional bleeding
Explorative Objective:
To explore tumor mutational burden with regard to
- solid tumor tissue by bronchoscopic forceps biopsy by bronchoscopic cryobiopsy
- cytologic material by (EBUS-guided) TBNA
- liquid biopsy
Target subject population Patients with suspected lung cancer or proven NSCLC and visible tumor suspicious lesion(s) requiring tissue diagnosis form the study population of this trial.
- Being tested
- Forceps biopsy, Cryobiopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forceps biopsyProcedure or surgery
Endobronchial biopsy with the forceps
CryobiopsyProcedure or surgery
Endobronchial biopsy with the cryobiopsy probe
| Study group | Role | What they receive |
|---|---|---|
| Forceps group | Active comparator | Not described Receives: Procedure: Forceps biopsy |
| Cryobiopsy group | Experimental | Not described Receives: Procedure: Cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of at least one molecular and/ or genetic alteration.
assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy
Measured: recruiting period approximately 24 months
Differences in the detection of total mutational burden between both techniques.
assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy
Measured: recruiting period approximately 24 months
Secondary outcomes (3)
Detection of any molecular and/ or genetic alterations
assessment of differences in detection rate of molecular genetic alterations in NSCLC between
- different bronchoscopic (forceps/ cryobiopsy) specimens (No 1 to No 4)
- liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
- combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
- naïve and processed tumor tissue specimen (eg. microdissection) To assess differences in side effects e.g. periinterventional bleeding
Measured: recruiting period approximately 24 months
Combinations of molecular and/ or genetic alterations
assessment of differences in detection rate of molecular genetic alterations in NSCLC between
- different bronchoscopic (forceps/ cryobiopsy) specimens (No 1 to No 4)
- liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
- combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
- naïve and processed tumor tissue specimen (eg. microdissection) To assess differences in side effects e.g. periinterventional bleeding
Measured: recruiting period approximately 24 months
Differences in the quantity of total mutational burden between the different techniques
assessment of differences in the quantity of total mutational burden between
- different bronchoscopic (forceps/ cryobiopsy) specimens (No 1 to No 4)
- liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
- combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
- naïve and processed tumor tissue specimen (eg. microdissection) To assess differences in side effects e.g. periinterventional bleeding
Measured: recruiting period approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start19 Dec 2018
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971175
- Sponsor's protocol ID
- PROFILER study
- Acronym
- PROFILER
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2019
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single Blinded Multicentre Trial to Evaluate Molecular Genetic Characterisation of Primary Diagnosed or Relapsed Non Small Cell Lung Cancer by Single or Combination of Diagnostic Procedures
- ClinicalTrials.gov ID
- NCT03971175
- Acronym / sponsor ID
- PROFILER / PROFILER study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study design Prospective multicentre explorative randomized single blinded study to evaluate accuracy of molecular genetic characterisation of NSCLC. Patients with suspected lung cancer are randomized in a 1:1-setting for bronchoscopic tumor tissue either by forceps or by cryobiopsy. Apart from the bronchoscopic techniques liquid biopsy of peripheral blood and if feasible transbronchial needle aspiration with or without endobronchial ultrasound guidance are performed for in all patients.
Objectives
Primary Objective:
assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy
Secondary Objective:
assessment of differences in detection of molecular genetic alterations in NSCLC between
- liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
- combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
- naïve and processed tumor tissue specimen (eg. microdissection)
To assess differences in side effects e.g. periinterventional bleeding
Explorative Objective:
To explore tumor mutational burden with regard to
- solid tumor tissue by bronchoscopic forceps biopsy by bronchoscopic cryobiopsy
- cytologic material by (EBUS-guided) TBNA
- liquid biopsy
Target subject population Patients with suspected lung cancer or proven NSCLC and visible tumor suspicious lesion(s) requiring tissue diagnosis form the study population of this trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forceps group | Active comparator | Procedure: Forceps biopsy |
| Cryobiopsy group | Experimental | Procedure: Cryobiopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent to the study and the study specific procedures prior to any study intervention
- Male or female patients aged ≥18 years
- Patients with primary diagnosis of suspected lung cancer OR Patients with known NSCLC and suspected relapse after therapy
- Bronchoscopically visible tumor
Key exclusion criteria (8 listed)
- Preexisting malignancy other than NSCLC
- Contraindication for bronchoscopy according to the international guidelines, daily clinical practice and the local regulations with
- Previous enrolment in the present study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forceps biopsyEndobronchial biopsy with the forceps | Procedure or surgery | Forceps group |
| CryobiopsyEndobronchial biopsy with the cryobiopsy probe | Procedure or surgery | Cryobiopsy group |
Primary outcome
Detection of at least one molecular and/ or genetic alteration.
Time frame: recruiting period approximately 24 months
assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy
Differences in the detection of total mutational burden between both techniques.
Time frame: recruiting period approximately 24 months
assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy
3 secondary outcomes
Detection of any molecular and/ or genetic alterations
Time frame: recruiting period approximately 24 months
Combinations of molecular and/ or genetic alterations
Time frame: recruiting period approximately 24 months
Differences in the quantity of total mutational burden between the different techniques
Time frame: recruiting period approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forceps biopsy and Cryobiopsy in people with Carcinoma, Non-Small-Cell Lung and Pathology, Molecular, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maik Haentschel, MD (+49707129 ext. 82711, maik.haentschel@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of at least one molecular and/ or genetic alteration. (time frame: recruiting period approximately 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.